Improving data transparency in clinical trials using blockchain smart contracts
Open accessAbstract
The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.
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Valid transactions stored in a blockchain are digitally signed and timestamped by their sender, providing cryptographically irrefutable evidence of both the provenance and the existence of a record at a given time.
“Valid transactions stored in a blockchain are digitally signed and timestamped by their sender, providing cryptographically irrefutable evidence of both the provenance and the existence of a record at a given time [4].”
From Tamper-Resistant Mobile Health Using Blockchain Technology. (2017) · cites this paper as [4]
There has been no study to evaluate the use of blockchain technology in an mHealth system.
“However, there has been no study to evaluate the use of blockchain technology in an mHealth system.”
From Tamper-Resistant Mobile Health Using Blockchain Technology. (2017) · cites this paper as [4]
The Introduction and Methods discuss blockchain for clinical-trial data management, and the Conclusions describe its potential to improve transparency. Our copy does not address whether any study has evaluated blockchain in an mHealth system (searched: mHealth, mobile health, and the claimed absence of studies). (LLM, conf=0.76)
Experimental — accuracy not yet measuredBlockchain technology has been proposed as a medium for health care data storage solutions [94,95] and as a tool for improving transparency in clinical trials [96].
“Gained a substantial attention in recent years T, the blockchain technology gained substantial popularity in recent years primarily due to the popularity of the Bitcoin crypto currency, was previously has been proposed as a medium for health care data storage solutions [94, 95] and as a tool for to improving thee transparency in clinical trials [96].”
From Converging blockchain and next-generation artificial intelligence technologies to decentralize and accelerate biomedical research and healthcare (2018) · cites this paper as [96]
Connecting Care is a blockchain-based record-sharing platform accessible in several English cities.
“Similarly, Connecting Care (Nugent et al. 2016) is a blockchain-based record-sharing platform accessible in several English cities.”
From Blockchain and Artificial Intelligence Technology in E-Health (2021) · cites this paper as Nugent et al. 2016
Blockchain is tamper-resistant, meaning information stored or generated on blocks can never be modified or tampered with in any case, neither while generating nor after generation.
“The blockchain is said to be tamper-resistant [50], which means that the information being stored or generated on the blocks of the blockchain can never be modified or tampered with in any case, neither while generating nor after the generation [51].”
From Security Aspects of Blockchain Technology Intended for Industrial Applications (2021) · cites this paper as [51]
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References 15 · Cited by 309
Research works printed but not linked: 1
- [11]Nugent T Upton D Cimpoesu M: Dataset 1 in: Improving data transparency in clinical trials using blockchain smart contracts. F1000Research. 2016 Data Source PMC5357027 28357041
- Authors
- Nugent, T., Upton, D., & Cimpoesu, M.
- Affiliations
- Thomson Reuters (United Kingdom) (GB)
- Corresponding author
- Nugent, Timothy
- Venue
- F1000Research
- Publisher
- F1000 Research Ltd
- Published
- 2016-10-20
- Volume
- 5
- Pages
- 2541
- ISSN
- 2046-1402 (ISSN-L)
- PMC
- PMC5357027
- OpenAlex
- W2538325702
- Cited by
- 309
- References
- 15
- Citations by year
- 2026: 10 · 2025: 24 · 2024: 30 · 2023: 54 · 2022: 31 · 2021: 51 · 2020: 44 · 2019: 39 · 2018: 20 · 2017: 6
- FWCI
- 48.49
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- F1000Research (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Physical Sciences › Computer Science › Information Systems › Blockchain Technology Applications and Security
- Physical Sciences › Computer Science › Information Systems › Blockchain Technology in Education and Learning
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- blockchain, smart contracts, clinical trials, data transparency, data manipulation, missing data, selective publication, p-hacking, immutable records
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